At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 1,395 enrolled

Drug / intervention

Sulopenem +4 moredrug

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03357614

NCT03357614Phase 3Completed

Compare CT.gov

Prospective, Phase 3, Randomized, Multi-center, Double-blind, Double-dummy Study of Efficacy, Tolerability & Safety of Sulopenem Followed by Sulopenem-etzadroxil/Probenecid vs Ertapenem Followed by Cipro for Treatment of cUTI in Adults

Iterum Therapeutics, International Limited·interventional·Posted Nov 30, 2017·Updated Dec 29, 2020

In Brief

A Phase 3 clinical trial evaluating Sulopenem, Sulopenem-Etzadroxil/Probenecid, and 3 other interventions for Complicated Urinary Tract Infections. Completed, enrolled 1,395 participants across 32 sites in 5 countries.

Detailed Summary

This is a prospective, phase 3, randomized, multicenter, double-blind, double-dummy study to compare the efficacy and safety of sulopenem followed by sulopenem-etzadroxil/probenecid versus ertapenem followed by ciprofloxacin for the treatment of complicated urinary tract infections (cUTI) in adults.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsComplicated Urinary Tract Infections

CountriesEstonia, Georgia, Hungary, Latvia, United States

Collaborators--

Timeline

Phase 3CompletedFinished

201820192020202120222023202420252026

First PostedNov 2017

Enrollment StartSep 2018

Primary CompletionDec 2019

TodayJul 2026

First PostedNov 30, 2017

Enrollment StartSep 18, 2018

Primary CompletionDec 14, 2019

TodayJul 2, 2026

Enrollment to primary: 1.2 yearsPosted 8.6 years ago